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Study to Evaluate Eupolio(IPV)'s Safety, Long-term Protective Effect and Boosting Effect of One Booster Dose in the Three Primary Vaccination Plus Boosting Schedule, and Protective Effect in the Schedule With Bivalent OPV in Infants

Primary Purpose

Poliomyelitis, Vaccine Reaction

Status

Recruiting

Phase

Phase 3

Locations

Philippines

Study Type

Interventional

Intervention

Eupolio

About this trial

This is an interventional prevention trial for Poliomyelitis

Eligibility Criteria

6 Weeks - 8 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Infants in stable health
Male or female 6 to 8 weeks of age
Signed informed consent by the infant's parent(s) or legally acceptable representative(s)

Exclusion Criteria:

Known or suspected poliomyelitis
Known or suspected febrile(symptom of a fever), or chronic illnesses
Fever ≥ 38.0℃/100.4℉ within 3 days prior to study registration or intake of drug preventing fever
Known or suspected immune disorders (abnormal activity in protective system in human body) or received immunosuppressive therapy (treatment for weaken protective system in human body)
Previous use of blood or blood-derived products
Previous use of polio vaccines
Seizures (temporary abnormalities in muscle tone or movements due to abnormal activity in the brain)
Bleeding disorders
Household contact or intimate exposure with a confirmed case of polio
Any history of allergy (hypersensitivity) to the components of the polio vaccine
Participation in another interventional clinical trial simultaneously or within 30 days

Sites / Locations

Philippine Heart CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Safety group

Immunogenicity group 1 (4 Eupolio including 1 boosting dose)

Immunogenicity group 2 (3bOPV+2 Eupolio)

Arm Description

Three doses of Eupolio will be administered at 6, 10 and 14 weeks of age. Only safety will be evaluated for this arm.

Three doses of Eupolio will be administered at 6, 10 and 14 weeks of age, and additional single dose of Eupolio will be administered one year after the three primary vaccinations.

bOPV will be administered at 6, 10 and 14 weeks of age, and Eupolio will be administered at 14 and 40 weeks of age.

Outcomes

Primary Outcome Measures

Immediate reaction

Any side effects that occur within 30 minutes after the vaccination

Solicited adverse event

Expected local or systemic side effects after vaccination

Unsolicited adverse event

All unwanted or bad events after vaccination other than solicited adverse event

Secondary Outcome Measures

Seroprotection rate

Proportion of infants who have more than 8 protective antibody titers

Geometric mean titers of neutralizing antibody against polio antigens

Geometric mean titers and log2 titers for protective antibody against poliovirus type 1, 2, and 3

Priming response

Proportion of infants who have more than 8 protective antibody titers after boosting dose, depending on protective state before boosting dose.

Seroconversion rate

Proportion of infants who have more than 8 protective antibody titers after three primary vaccinations, depending on protective state before vaccination.

Full Information

NCT ID

NCT05431933

First Posted

June 17, 2022

Last Updated

March 7, 2023

Sponsor

LG Chem

1. Study Identification

Unique Protocol Identification Number

NCT05431933

Brief Title

Study to Evaluate Eupolio(IPV)'s Safety, Long-term Protective Effect and Boosting Effect of One Booster Dose in the Three Primary Vaccination Plus Boosting Schedule, and Protective Effect in the Schedule With Bivalent OPV in Infants

Official Title

A Multicenter, Open-label, Interventional Phase 3b Study to Evaluate the Safety, One-year Antibody Persistence, Priming Immune Responses of Three Doses of Eupolio Inj. (Inactivated Polio Vaccine (Sabin Strains)) and Immunogenicity of Two Doses of Eupolio Inj. Following Three Doses of bOPV in Infants

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 10, 2023 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LG Chem

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Eupolio is inactivated poliovirus vaccine (IPV). Major purpose of this study is to evaluate safety of Eupolio in 2,000 infants. In addition to the safety, long-term protection after completion of the three primary vaccinations and extent of protective level after a single boosting dose of Eupolio will be evaluated. As IPV plus bOPV vaccination schedule (3 doses of bOPV plus 2 doses of IPV in infant-toddle vaccination schedule) has been implemented in some countries, this study will also evaluate Eupolio's safety and protective effect in that schedule.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Poliomyelitis, Vaccine Reaction

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Safety group

Arm Type

Experimental

Arm Description

Three doses of Eupolio will be administered at 6, 10 and 14 weeks of age. Only safety will be evaluated for this arm.

Arm Title

Immunogenicity group 1 (4 Eupolio including 1 boosting dose)

Arm Type

Experimental

Arm Description

Three doses of Eupolio will be administered at 6, 10 and 14 weeks of age, and additional single dose of Eupolio will be administered one year after the three primary vaccinations.

Arm Title

Immunogenicity group 2 (3bOPV+2 Eupolio)

Arm Type

Experimental

Arm Description

bOPV will be administered at 6, 10 and 14 weeks of age, and Eupolio will be administered at 14 and 40 weeks of age.

Intervention Type

Biological

Intervention Name(s)

Eupolio

Intervention Description

Inactivated Polio vaccine (Sabin strains)

Primary Outcome Measure Information:

Title

Immediate reaction

Description

Any side effects that occur within 30 minutes after the vaccination

Time Frame

30 minutes after each vaccination

Title

Solicited adverse event

Description

Expected local or systemic side effects after vaccination

Time Frame

7 days after each vaccination

Title

Unsolicited adverse event

Description

All unwanted or bad events after vaccination other than solicited adverse event

Time Frame

28 days after each vaccinations

Secondary Outcome Measure Information:

Title

Seroprotection rate

Description

Proportion of infants who have more than 8 protective antibody titers

Time Frame

4 weeks after the third vaccination, 52 weeks after the third vaccination and 7 days after the boosting vaccination in the 4 Eupolio group/ 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group

Title

Geometric mean titers of neutralizing antibody against polio antigens

Description

Geometric mean titers and log2 titers for protective antibody against poliovirus type 1, 2, and 3

Time Frame

4 weeks after the third vaccination, 52 weeks after the third vaccination and 7 days after the boosting vaccination in the 4 Eupolio group / 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group

Title

Priming response

Description

Proportion of infants who have more than 8 protective antibody titers after boosting dose, depending on protective state before boosting dose.

Time Frame

7 days after the boosting vaccination in the 4 Eupolio group

Title

Seroconversion rate

Description

Proportion of infants who have more than 8 protective antibody titers after three primary vaccinations, depending on protective state before vaccination.

Time Frame

4 weeks after the third vaccination in the 4 Eupolio group / 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Maximum Age & Unit of Time

8 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Infants in stable health Male or female 6 to 8 weeks of age Signed informed consent by the infant's parent(s) or legally acceptable representative(s) Exclusion Criteria: Known or suspected poliomyelitis Known or suspected febrile(symptom of a fever), or chronic illnesses Fever ≥ 38.0℃/100.4℉ within 3 days prior to study registration or intake of drug preventing fever Known or suspected immune disorders (abnormal activity in protective system in human body) or received immunosuppressive therapy (treatment for weaken protective system in human body) Previous use of blood or blood-derived products Previous use of polio vaccines Seizures (temporary abnormalities in muscle tone or movements due to abnormal activity in the brain) Bleeding disorders Household contact or intimate exposure with a confirmed case of polio Any history of allergy (hypersensitivity) to the components of the polio vaccine Participation in another interventional clinical trial simultaneously or within 30 days

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Study Lead

Phone

+82-2-3777-1114

yangyj@lgchem.com

Facility Information:

Facility Name

Philippine Heart Center

City

Quezon City

Country

Philippines

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

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